Product Complaint Manager

Boston Scientific•Georgetown, MA

2d•Hybrid

About The Position

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. Responsible for leading Post Market Vigilance staff and overseeing all compliance activities related to the complaint handling program at Boston Scientific. This role ensures alignment with corporate, domestic and international regulatory requirements, including FDA regulations (21 CFR Parts 820 and 803) and applicable global standards. You will drive the effectiveness of complaint processes, support risk management activities and serve as a key quality liaison across functions to ensure product safety, regulatory compliance and continuous improvement.

Requirements

Bachelor’s degree
Minimum of 7 years' experience in the medical device industry
Minimum of 3 years' experience in a leadership role within the medical device industry

Nice To Haves

Experience leading audits, including front room and back room support
Knowledge of U.S. and international regulatory reporting requirements
Experience working with competent authorities
Strong management and communication skills
Project management experience
Proven team leadership experience
Experience with endoscopy products
Experience with post-market surveillance activities
Vendor management experience

Responsibilities

Ensure all complaints are reviewed, evaluated and investigated to determine reportability to the FDA and international regulatory authorities
Monitor daily operations and provide direction to supervisors, exempt employees and nonexempt staff to achieve team and project goals
Plan for the impact of new products, including training, implementation and control plans
Maintain processes and procedures to ensure compliance with corporate policies and external regulations and standards
Contribute to the development of operational policies and procedures impacting the assigned organizational unit
Monitor compliance with company policies and applicable regulations, including FDA and international standards
Initiate and implement corrective and preventive actions in accordance with established procedures
Partner with internal and external stakeholders by responding to requests, leading discussions and explaining processes
Interact with internal, domestic and international auditors during audits and inspections
Coordinate and support escalation of adverse complaint trends and product issues
Ensure appropriate training is provided to Post Market Surveillance staff
Manage performance, professional development and growth of team members
Assess and address ongoing skill and development needs to ensure team capability
Recommend staffing and resource needs to meet business and compliance objectives
Oversee the accuracy, completeness and maintenance of complaint records in the global complaint management database
Monitor internal and external indicators through reports, publications and cross-functional engagement
Contribute to budget planning and monitoring through cost and spending analysis